Randomized, double-blind, placebo-controlled phase 3 trials of linagliptin included in this pooled analysis
| Reference | ClinicalTrials.gov identifier | Treatment regimen | Treated set, N | Duration (weeks) | Hispanic/Latino patients, n (%) | HbA1c inclusion criteria at screening, per cent |
|---|---|---|---|---|---|---|
| Barnett et al12 | NCT00740051 | Monotherapy | Linagliptin: 151 Placebo: 76 | 18 | Linagliptin: 31 (20.5) Placebo: 14 (18.4) | 7.0–10.0 if treatment naïve (7.0–9.0 in Canada) 6.5–9.0 if receiving an OAD |
| Haak et al13 | NCT00798161 | Monotherapy* | Linagliptin: 142 Placebo: 72 | 24 | Linagliptin: 14 (9.9) Placebo: 10 (13.9) | 7.5–11.0 if treatment naïve 7.0–10.5 if receiving an OAD |
| Taskinen et al14 | NCT00601250 | Combination with metformin | Linagliptin: 523 Placebo: 177 | 24 | Linagliptin: 110 (21.0) Placebo: 32 (18.1) | 7.0–10.0 if treated with metformin monotherapy 6.5–9.0 if treated with metformin and an additional medication |
| Lewin et al15 | NCT00819091 | Combination with sulfonylurea | Linagliptin: 157 Placebo: 81 | 18 | Linagliptin: 25 (15.9) Placebo: 14 (17.3) | 7.5–10.0 if treated with sulfonylurea monotherapy 7.0–9.0 if treated with sulfonylurea and another OAD |
| Owens et al16 | NCT00602472 | Combination with metformin+sulfonylurea | Linagliptin: 792 Placebo: 263 | 24 | Linagliptin: 176 (22.2) Placebo: 57 (21.7) | 7.0–10.0 |
| Yki-Järvinen et al17 | NCT00954447 | Combination with basal insulin±metformin and/or pioglitazone | Linagliptin: 628 Placebo: 627 | 24† | Linagliptin: 122 (19.4) Placebo: 140 (22.3) | 7.0–10.0 |
*Patients were randomized to one of six treatment arms including initial combination therapy, but only Hispanic/Latino patients from the linagliptin monotherapy and placebo arms were pooled for these analyses.
†This study was 52 weeks in duration, but with a primary efficacy endpoint at 24 weeks.
HbA1c, glycated hemoglobin; OAD, oral antidiabetes drug.